Pain, Central Sensitization and Psychoemotional State in Patients With Chronic Masticatory Muscle Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Diagnostic Criteria for Temporomandibular Disorders Clinical Examination, Blood test.
- Who it may be relevant to
- Registry conditions: TMD, Masticatory Muscle Pain. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Assessment of the Relationship Between Pain, Central Sensitization and Psychoemotional State in Patients With Chronic Masticatory Muscle Pain
Overview
The aim of this study is to investigate the relationship of psychological aspects, selected blood parameters, pain, central sensitization, and muscle electromyography activity in patients with chronic masticatory muscle pain.
Detailed description
In this prospective cohort study, the study group will consist of 51 people with masticatory muscle pain lasting longer than 3 months, while the control group will involve 51 people without such disorder.
Muscle type of temporomandibular disorders will be diagnosed on the basis of validated and standardized DC/TMD protocol.
Additionally potential headaches will be assessed according to the ICHD-3, since coexistence of chronic masticatory muscle pain and headache is often observed.
Psychological aspects will be analyzed using validated questionnaires regarding depression (PHQ-9), anxiety (GAD-7), perceived stress (PSS-10), satisfaction with life (SWLS), type D personality (DS-14) and coping with stress (Mini-COPE). Central Sensitization will be assessed using the Central Sensitization Inventory. Following blood substances will be assessed: serotonin, dopamine, Gamma-aminobutyric acid (GABA), Tumor Necrosis Factor α (TNF-α), CGRP, SERT, interleukin 1B, interleukin 6, interleukin 8, interleukin 10 and interleukin 17A. Additionally two polymorphisms of genes encoding proteins for serotonin receptors HTR2A - rs4941573 in intron 3 and dopamine DRD3 - rs6280 (Ser9Gly) will be analyzed.
Pain assessment will be done using a validated and standardized questionnaire regarding chronic pain (GCPS) and an algometer and will include the measurement of pressure pain threshold in masseter and temporal muscles. In addition, potential autonomic disorders will be assessed using Autonomic Symptoms Questionnaire proposed by Low. Electromyographic muscle activity will be assessed by tetany test. The results of the study will allow for deeper understanding of the complex nature of orofacial pain of muscle origin and its connection with the mechanism of central sensitization, headache and muscle electromyographic activity. Measurement of blood parameters will provide more accurate information on the pathophysiology of these disorders and the use of validated questionnaires will provide valuable information about the mental state of patients.
Interventions
- Diagnostic test Diagnostic Criteria for Temporomandibular Disorders Clinical Examination
Clinical examination made by experienced dentists (minimum 5 years of practice) and trained and calibrated in accordance with the protocol available on the DC/TMD. - Diagnostic test Blood test
Blood samples will be tested to investigate two polymorphisms of genes encoding proteins for serotonin receptors HTR2A - rs4941573 in intron 3 and dopamine DRD3 - rs6280 (Ser9Gly) and levels of serotonin, dopamine, Gamma-aminobutyric acid (GABA), Tumor Necrosis Factor α (TNF-α), CGRP, SERT, interleukin 1B, interleukin 6, interleukin 8, interleukin 10 and interleukin 17A.
Primary outcome measures
- Relationship between masticatory muscle pain and polimorphism of serotonin receptor gene HTR2A - rs4941573 and dopamine receptor gene DRD3 - rs6280 [Time frame: January 3, 2023 - January 3, 2024]
- Relationship between masticatory muscle pain and serotonin and dopamine levels. [Time frame: January 3, 2023 - January 3, 2024]
- Relationship between masticatory muscle pain and Gamma-aminobutyric acid (GABA), Tumor Necrosis Factor α (TNF-α), CGRP, SERT, interleukin 1B, interleukin 6, interleukin 8, interleukin 10 and interleukin 17A. [Time frame: January 3, 2023 - January 3, 2024]
Secondary outcome measures (8)
- Relationship between masticatory muscle pain and depression assessed by Patient Health Questionnaire. [Time frame: January 3, 2023 - January 3, 2024]
- Relationship between masticatory muscle pain and PPTs. [Time frame: January 3, 2023 - January 3, 2024]
- Relationship between masticatory muscle pain and anxiety assessed by Generalized Anxiety Disorder -7. [Time frame: January 3, 2023 - January 3, 2024]
- Relationship between masticatory muscle pain and perceived stress assessed by Perceived Stress Scale. [Time frame: January 3, 2023 - January 3, 2024]
- Relationship between masticatory muscle pain and satisfaction with life assessed by Satisfaction With Life Scale. [Time frame: January 3, 2023 - January 3, 2024]
- Relationship between masticatory muscle pain and Type D personality assessed by DS-14 quesstionaire. [Time frame: January 3, 2023 - January 3, 2024]
- Relationship between masticatory muscle pain and coping with stress assessed by mini COPE. [Time frame: January 3, 2023 - January 3, 2024]
- Relationship between masticatory muscle pain and central sensitization assessed by Central Sensitization Inventory. [Time frame: January 3, 2023 - January 3, 2024]
Eligibility criteria
Inclusion Criteria for study group:
- Masticatory muscle pain for at least 3 months, based on DC/TMD, at least 18 y.o
Exclusion criteria
- severe neurological or psychiatric diseases, use of drugs that may affect the neuromuscular system, alcohol or drug addiction, cancer or pregnancy, previous head surgery
Inclusion criteria for control group:
- no pain in masticatory muscles, age of at least 18 y.o Exclusion criteria the same as for study group
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Poland · 1 center
- Wroclaw Medical University — Wroclaw
Identifiers
NCT: NCT05676827 · WMU1/2022